FujiFilm Medwork FOR Serie Manual Del Usuario página 3

Instructions for use
Intended use
The FOR Series instruments are used for the manipulation and extraction of foreign
bodies from the upper and lower gastrointestinal tract.
Product features
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Qualification of user
Use of these instruments requires comprehensive knowledge of the technical princip-
les, clinical applications and risks of gastrointestinal endoscopy. The instruments
should only be used by or under the supervision of physicians who are adequately
trained and experienced in endoscopic techniques.
General instructions
Use this instrument only and exclusively for the purposes described in these instruc-
tions.
ATTENTION! Instruments marked with this symbol are intended for single use
only and are sterilised with ethylene oxide.
Sterile instruments can be used immediately. Before use, check the "Use by" date on
the packaging, as sterile instruments are only allowed to be used up to this date.
Do NOT use the instrument if the sterile packaging has tears or perforations, sealing is
not ensured or moisture has penetrated. All medwork instruments should be stored in
a dry place that is protected from light. Keep all instructions for use in a safe and
easily accessible place.
medwork instruments that are labelled as intended for single use only must not be
reprocessed, resterilised or reused. Reuse, reprocessing or resterilisation can alter
product properties, resulting in functional failure that can endanger the patient's health
or lead to disease, injury or death. Reuse, reprocessing or resterilisation furthermore
entails the risk of contamination of the patient or the instrument, as well as the risk of
cross contamination, including the transmission of infectious diseases. Contamination
of the instrument can result in illness, injury or death of the patient.
Indications
Resected tissue (e.g. polyps), food bolus impaction, foreign body ingestion.
Contraindications
The contraindications for the FOR series are the same as the specific contraindica-
Gripper
Dual-ring handle
Thumb ring
Branches
Control
Thumb ring
tions for oesophagogastroduodenoscopy, colonoscopy, sigmoidoscopy, rectoscopy
and enteroscopy.
Possible complications
Perforation, haemorrhage, infection, sepsis, allergic reaction to medicines, hypertensi-
on, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.
Precautions
In order to ensure that the examination proceeds smoothly, the diameter of the
endoscope working channel and the diameter of the instruments must be matched to
one another.
After removal from the packaging, check the instruments for correct function, kinks,
fractures, rough surfaces, sharp edges and protrusions. If you discover any damage or
malfunction on the instruments, do NOT use them and inform your responsible field
service contact or our branch office.
Any person who markets or uses medical devices is required to report any serious
incident that has occured in relation to the device to the manufacturer and the compe-
tent authority of the Member State in which the user and/or patient is established.
Attention! For the extraction of sharp objects we recommend using an endoscope
cap or an overtube. Deploy the foreign body retrieval instrument only when visible at
the distal end of the instrument. During foreign body retrieval in the upper gastrointes-
tinal tract make sure the foreign body is completely and firmly anchored in the foreign
body retrieval instrument so that any loss of the foreign body will not lead to aspiration.
Instructions for use
Perform the diagnostic endoscopy and adjust the tip of the endoscope to the foreign
body to be extracted. Guide the foreign body removal instrument with closed grippers
or branches through the working channel of the endoscope until the tip of the instru-
ment comes into endoscopic view. Open the gripper or branches by operation of the
dual-ring handle or the control and grasp the foreign body for extraction. Close the
gripper of branches carefully with light pressure. Excessive pressure might damage
the inner traction cable of the foreign body removal instrument. Carefully withdraw the
endoscope from the mouth together with the foreign body collected.
After completion of the surgical procedure
Instruments intended for single use, including packaging, must be disposed of in
accordance with the relevant applicable hospital and administrative guidelines and in
accordance with the relevant applicable legal regulations.
List of all icons used on medwork products
Date of manufacture
Follow the instructions
for use
Applied part Type BF
Batch code
Item number
Packaging unit
Do not reuse
Sterilised using
ethylene oxide
Non-sterile
Manufacturer
Sterile barrier system
English
Use by
Caution near pacemakers
Do not use if packaging
is damaged
Not suitable for lithotripsy
Contains natural rubber
latex
Gastroscopy
Colonoscopy
Enteroscopy
ERCP
Medical device